The Clinical Trials Regulation (Regulation (EU) No 536/2014) becomes applicable on 31 January 2022 and the Clinical Trials Information System (CTIS) will go live.

Webinar for small and medium-sized enterprises (SMEs) and academia on the Clinical Trials Regulation and the Clinical Trials Information System (CTIS):

https://www.ema.europa.eu/en/events/webinar-small-medium-sized-enterprises-smes-academia-clinical-trials-regulation-clinical-trials

In 2021, EMA plans to focus on:

• the findings of a system audit;
• improving usability, quality and stability of the CTIS;
• knowledge transfer to prepare users and their organisations for CTIS.

It is also working towards go-live in line with a plan developed together with the Member States and to deliver a minimum viable product (MVP). The CTIS programme governance is responsible for agreeing what the MVP will consist of.

Go live is planned in December 2021. For more information click here:

https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trial-regulation

World Health Organisation (WHO) “Guideline on Data Integrity” is undergoing consolidation of comments received and review of the feedback with an aim of completion in 2020.

https://www.who.int/medicines/areas/quality_safety/quality_assurance/QAS19_819_rev1_guideline_on_data_integrity.pdf?ua=1

On 31st July 2020 MHRA updated “Good clinical practice for clinical trials” on their website available. Guidance for the notification of serious breaches of GCP or the trial protocol, and the form for their notification, have been updated.

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/905577/Guidance_for_the_Notification_of_Serious_Breaches_of_GCP_or_the_Trial_Protocol_Version_6__08_Jul_2020.pdf

V piatok 3.7.2020 o 9:00 vám náš nový GCP portál predstavíme na prvom webinári. Účasť je bezplatná, stačí, keď sa nám ozvete na elearning@medius.sk a my vám následne zašleme link a heslo, cez ktorý sa prihlásite.

Tešíme sa na stretnutie s vami!

Dávame vám do pozornosti zrozumiteľné, odborné a veľmi užitočné podcasty na aktuálne témy tohto obdobia. Celú podcastovú sériu nájdete na: https://www.medipravnik.sk/podcasty/.

Prajeme vám príjemné počúvanie!